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Method for providing enteric coating on solid dosage forms and aqueous compositions therefor
| Details |
Inventors: Onda, Yoshiro; Muto, Hiroaki; Suzuki, Hiroshi; Maruyama, Kazumasa; Hatayama, Atsushi;
Assignee: Shin-Etsu Chemical Co., Ltd. (Tokyo, JP)
Primary Examiner: Lieberman; Allan
Assistant Examiner: Short; Patricia
Attorney, Agent or Firm: Toren, McGeady and Stanger
A novel aqueous coating composition is proposed for providing enteric coating on solid dosage forms such as tablets. The aqueous coating composition of the invention comprises a fine powder of an enterosoluble cellulose derivative such as hydroxypropylmethylcellulose phthalate and hydroxypropylmethylcellulose acetate succinate, which is insoluble in water but can be plasticized and solubilized with certain plasticizing agents, as dispersed in an aqueous dispersing medium and a plasticizing agent having compatibility with the enterosoluble cellulose derivative and dissolved in the aqueous dispersing medium. The particle size of the enterosoluble cellulose derivative and the boiling point of the plasticizing agent is the key parameters and should be finer than 100 .mu.m in an average particle diameter and not lower than 100.degree. C., respectively. Upon application of the aqueous coating composition to the solid dosage forms, water as the dispersing medium is first evaporated leaving the cellulose derivative and the plasticizing agent, which latter solubilizes the former to form a continuous coating layer on the solid dosage forms imparting good and satisfactory enterosolubility thereto. |
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Extensive investigations have been undertaken by the inventors with an object to solve the above described problems in the prior art enteric coating compositions leading to the establishment of a novel method for providing enteric coating on various solid dosage forms and an aqueous enteric coating composition as described above suitable for practicing the objective method.
The enterosoluble cellulose derivatives to be dispersed in water or in an aqueous medium as the dispersing medium are not limited to particular ones but may be any one of known cellulose derivatives derived from various kinds of alkyl ethers of cellulose, hydroxyalkyl ethers of cellulose, monocarboxylic acid esters of cellulose and mixed cellulose ester ethers with a combination of two or more of alkyl, hydroxyalkyl and monocarboxyl groups by monoesterification with a dibasic or tribasic carboxylic acid.
The above mentioned alkyl and hydroxyalkyl ethers of cellulose are exemplified by methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxybutylcellulose, hydroxyethylethylcellulose, hydroxypropylmethylcellulose, hydroxybutylmethylcellulose and the like and the monocarboxylic acid esters of cellulose are exemplified by the esters of cellulose with acetic acid, butyric acid, propionic acid and the like.
The dibasic and tribasic acids are exemplified by phthalic acid, tetrahydrophthalic acid, trimellitic acid, maleic acid, succinic acid, glutaric acid and the like, of which the dibasic acids are preferred to the tribasic.
Thus, some of the examples of the enterosoluble cellulose derivatives suitable for use in the present invention are hydroxypropylmethylcellulose phthalate, cellulose acetate phthalate, hydroxypropylmethylcellulose acetate succinate, hydroxypropylcellulose phthalate and the like.
As is described above and undermentioned in further detail, these enterosoluble cellulose derivatives are used as dispersed in water or an aqueous medium to form an aqueous enteric coating composition so that the maximum particle size or the particle size distribution of the cellulose derivative is an important parameter
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